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ICSI (intracytoplasmic sperm injection) is a successful treatment when there are male fertility problems, but it is often used more widely in fertility clinics – and some offer ICSI to many patients where there is no male factor problem at all. Now, new research presented at ESHRE (the European Society of Human Reproduction and Embryology) shows that there is no benefit to offering ICSI unless there is a male fertility issue.

ICSI was developed in the 1990s as a breakthrough treatment for men who would otherwise have had to use donor sperm to become a parent, but now it is used so often that twice as many ICSI cycles are carried out around the world as IVF cycles. In some countries all assisted conception cycles are ICSI.

This large study of almost 5000 patients in Belgium and Spain being treated with ICSI or IVF found there was no benefit to using ICSI where there was no male fertility problem. The results of the study were presented by Dr Panagiotis Drakapoulos from UZ Brussels, the Belgian centre where ICSI was developed more than 25 years ago. The study was a collaboration between the Brussels centre and 14 clinics in Spain.

The reason given for using ICSI is often that it is thought it results in a higher chance of fertilisation and more embryos, but this large study showed no overall difference in outcome using IVF or ICSI regardless of whether the female patients had large numbers of eggs (more than 15) or not so many (1-3) – so there is no rationale for using it to try to improve outcomes in cycles where there are just a few eggs.

The use of ICSI varies around the world, with the highest rates in many countries of Eastern and Mediterranean Europe. There is a slightly lower use in some Nordic countries, the UK and France. In its latest review of treatment trends in the UK, the HFEA reported that ICSI use ‘continued to increase until 2014, but it is now in decline, possibly due to clinical opinion that it’s not needed in all contexts of IVF’.

This reflects the message from this study, which, according to Dr Drakapoulos, found ‘no justification for the use of ICSI in non-male factor infertility’. He added that the number of eggs retrieved ‘should not play any role in selecting the insemination method’. Dr Drakapoulos also highlighted the extra financial cost of ICSI over IVF.

We’re all very aware of the female biological clock, but what we don’t hear so so much about is the fact that male sperm counts decline and DNA damage in sperm cells may increase as men get over. The fact that some high-profile men have become fathers when they are pensioners perpetuates the myth that male fertility lasts forever.

In fact, evidence shows men do have a biological clock with a decline in natural male fertility and an increase in the miscarriage rate as men get older. New evidence at ESHRE from one London fertility clinic shows that IVF/ICSI is less likely to succeed if a male partner is over 51 too.

Dr Guy Morris from the Centre for Reproductive and Genetic Health (CRGH) in London presented results at the ESHRE (European Society of Human Reproduction and Embryology) conference of an analysis of more than 5000 IVF/ICSI cycles which found that although there was no difference in miscarriage rates, there was a significant reduction in the chances of success

The results showed that that clinical pregnancy rate declined as men got older – from 49.9% when men were under 35, to 42.5% for men aged 36-40, 35.2% for those aged 41-45, 32.8% for those aged 46-50, and 30.5% in the over 51s.

The researchers also noted that 80% of couples where the male partners were over 51 were treated with ICSI, a treatment developed for male infertility. Dr Morris said: ‘There may well be a public perception that male fertility is independent of age. Stories of celebrity men fathering children into their 60s may give a skewed perspective on the potential risks of delaying fatherhood. Indeed, in natural conception and pregnancy it is only recently that evidence of risks associated with later fatherhood has become available. These more recent studies contrast with decades of evidence of the impact that maternal age has on fertility outcomes. In the context of this emerging evidence for the deleterious effect of increasing paternal age, our data certainly support the importance of educating men about their fertility and the risks of delaying fatherhood.’

Most people having fertility treatment are keen to absolutely anything they can to try to boost their chances of success, and sometimes that can mean paying for additional treatments as well as their IVF or ICSI which they hope can increase the likelihood that they will get pregnant. The problem with many of these treatments is that there is not yet sufficient evidence to be able to say that they will do what they claim to do, but fertility patients sometimes decide to have them anyway.

One treatment offered by some clinics is related to the level of natural killer (NK) cells in a woman’s body – the very name suggests that having a lot of these must inevitably be a bad thing. If you are considering having your NK cells tested as part of your fertility treatment, you may be interested in reading this article which explains the growing understanding that at least some of a woman’s natural killer cells act as peacekeepers, preventing other immune cells from attacking the fetus. They also produce chemicals which promote the growth of the baby and blood vessel connections.

You can read more about all fertility treatment add-ons on the HFEA website, where each of the different treatments has been ranked according to the latest scientific evidence and given a traffic light grading.

If you have five minutes, would you be able to complete a quick survey to help with the design of a study looking at women’s long term health after fertility treatment. The purpose of this survey is to learn about your views and health concerns regarding Assisted Reproductive Technology (ART) which covers all forms of IVF/ICIS.

To date, little research has examined women’s health after fertility treatment. University College London is designing a study to monitor women’s long term health after ART and your opinion, views and concerns will help them to design and develop a study, taking into account women’s specific concerns about this topic. This survey is open to all women, whether or not they have had fertility treatment so you can share it with other people. It is anonymous and you can find it by clicking on the link – https://www.surveymonkey.co.uk/r/QY26FR7

I gave a talk at The Fertility Show on Saturday about add ons, and promised to put my notes on the blog, so these are some of the key points, and links to useful sources of information.

What are add-ons?

They are additional treatments which your clinic may offer on top of IVF/ICSI

They are new or emerging treatments and there may be limited evidence about how effective they are

Some may have shown some promising results in initial studies but may not be proven to improve pregnancy or birth rates

Some clinics offer lots of add ons and may give you what looks like a shopping list of additional treatments to choose from. Some don’t offer them. This isn’t an indication of how good or forward-thinking a clinic is – some fertility experts may not be convinced that some add ons are worthwhile or safe.

Some clinics charge for add ons, others may include particular add ons in the cost of treatment because they think they make a difference and believe they should be part of IVF.

Add ons can be expensive and may substantially increase what you pay for your IVF

It can be difficult to know what to think about these new treatments, and the HFEA carried out patient survey to try to find out what people thought. The views ranged from those who were very strongly in favour of add ons to those who felt patients should not be offered treatments that we don’t know work. The overwhelming feeling from patients was that they didn’t want to miss out on something which might make a difference, but that this had to be balanced by the need to protect their interests.

Assessing the evidence is key and you want to know is:

What evidence there is about how effective something is

What evidence there is about whether it is safe

Does it carry any risks

How much does it cost

How do you assess the evidence?

As lay people, when we hear about evidence we may give any research or scientific paper equal weight, but in fact evidence isn’t quite as black and white as we may think.

The best scientific evidence comes from randomised controlled trials. In these trials, people will be divided into those who have the new technique or treatment and those who don’t in a randomised way. It is important when assessing evidence to look at whether the study included all patients or just a specific group. Sometimes research may have a narrow age range, or may have only looked at people with one specific type of fertility problem.

You should also look at the number of people included in the study. The most meaningful research will have involved a large group but sometimes you may discover that studies have taken place in one specific clinic and may involve tiny numbers of people.

Finally, check the outcomes. You want to look at studies where a healthy live birth is the outcome but some studies may stop at a fertilised egg or positive pregnancy test and this may not translate into an increase in births.

How the HFEA can help

The HFEA got together a group of leading scientists and fertility experts to look at all the existing research on each of the add ons, to assess it and to develop a traffic light system for add ons.

There is a green symbol where there is more than one good quality study which shows that the procedure is effective and safe.

A yellow symbol where there is a some evidence or some promising results but where further research is still required.

And a red symbol where there is no evidence to show something works or that it is safe

The decisions made by the group were then re-assessed by an expert in evidence to ensure every traffic light had been correctly assigned.

Green lights

Not one of the add ons mentioned at the start was given a green light to say that there is “more than one good quality study which shows that the procedure is effective and safe”

Red lights

There are a few red lights which means there is currently no evidence for assisted hatching, intrauterine culture, PGS on day three and reproductive Immunology. There may also be risks here too so do read the evidence carefully on the HFEA’s information page.

Amber lights

A lot of the add ons fall into amber where more evidence is needed. This includes endometrial scratch, freeze all cycles, egg activation, embryo glue, PGS on day five or six and time lapse.

For two of the add ons in this category, freeze-all cycles and endometrial scratch, there are big multi-centre trials going on at present in clinics across the United Kingdom. If you want one of these add ons, ask your clinic if they are taking part in the trial as you could end up getting the add on itself free of charge (this doesn’t cover the cost of the IVF/ICSI and you may be randomised into the other part of the trial and not get the add on, but it may be a good way forward if can’t afford to pay for the add on)

The cost of add ons

Some clinics offer add ons such as embryo glue or time lapse as part of a treatment cycle to every patient they treat. Others charge, and prices can vary hugely. There is often no discernible reason for wide discrepancies in price, so do look into this by finding out what a number of different clinics are charging for any add on you are considering.

Key questions

If your clinic offers you an add on, make sure you ask some questions first:

If you pay for it, would it affect your chances of being able to pay for another cycle if it doesn’t work?

Whatever you decide,make sure you are as fully informed as you can be about your treatment, and make sure you have read through all the evidence on the HFEA website which is there to help you to make an informed decision about your treatment.

There are also a couple of very helpful videos on what it’s like to have IVF and ICSI. You can find out much more by having a look at the HFEA’s posts and you can follow for regular updates from the Authority.

If you’ve had fertility treatment recently or are currently having treatment at a UK clinic, did you know that you can give a review of your clinic’s services on the HFEA website? Your reviews are used to create a patient rating for the clinic which other people can then see on the website along with the outcomes from treatment there and a ranking from the HFEA inspectors.

It’s good to do this if you have a spare moment – and it really won’t take long – as it helps to build up a picture of the clinic for others who may be considering having treatment there. You will be asked a series of questions about the clinic such as

How likely are you to recommend this clinic to friends and family if they needed similar care or treatment?

To what extent did you feel you understood everything that was happening throughout your treatment?

To what extent did you feel you were treated with privacy and dignity?

What was the level of empathy and understanding shown towards you by the clinic team?

You will also be asked about cost for those who had to pay for treatment and you will be able to say whether it was more, less or about the same as you’d been anticipating. Finally, you are able to add any further comments about your experiences which will be seen by the regulator but will not appear on the website.

Choosing a fertility clinic is not easy, particularly if you live in London and the South East where there are so many clinics to choose from, and the views of other people who’ve been to a clinic can be useful.

If you are having fertility treatment, or have done recently, you may have been offered some additional extras on top of your IVF or ICSI. These additional treatments include things like time-lapse imaging, embryo glue, endometrial scratching or reproductive immunology. Not all clinics offer every type of additional treatment. Some may not suggest them at all, others include them in the price of IVF or you may be given the option to pay for add ons if you would like them.

Fertility Network UK, the patient charity, and the fertility regulator the Human Fertilisation and Embryology Authority, or HFEA, is interested in finding out more about what you think about these add ons, how they should be offered and what you need in order to make decisions about whether to pay for them. Most of these add ons are not fully proven to increase your chance of getting pregnant.

If you have had treatment recently or are going through treatment currently, do take a minute to answer the short questionnaire to help them find out more about what your views are on this subject. You can find the link by clicking here

It uses data from the Human Fertilisation and Embryology Authority which keeps records of all cycles of treatment carried out in the UK, to aim to give a picture of your individual chances of having a baby after IVF/ICSI treatment,

The reporting of this has been analysed by NHS Choices which points out that there are some gaps in the data which the researchers themselves have acknowledged as it doesn’t account for the woman’s body mass index (BMI), whether she smokes and how much alcohol she drinks.

Despite these limitations, it is certainly a very useful tool and one which may help many couples get some kind of realistic idea of the chances of an IVF cycle working. Of course, the experience of each individual couple is always different and this doesn’t allow you to include any detailed medical data either, but it does give a broad picture view which may prove very helpful.

Those of you who came to my talk at the Fertility Show will know that I promised to put up some notes from my talk on the blog this week – here they are at last!

The HFEA website

We begin with the HFEA websitewhich is the best place to start. You can search for your local clinic using the Choose a Clinic tool – just type in your postcode or local region and you will get a shortlist of local clinics.

You can see more about the treatments they are licensed to carry out, services, facilities and staff. It will tell you whether they take NHS patients, the opening hours, whether there is a female doctor and links to a map.

Of course, the one thing you really want to know is how likely am I to get pregnant there? Which is the one thing no one can honestly tell you. The HFEA publishes success rates for all licensed clinics, but they may not be as clear cut as you imagine. Most clinics have broadly similar success rates and the majority of clinics in UK have success rates which are consistent with national average. Don’t forget, the patients treated affect the success rates.

You may want to look at the success rate for someone of your age, and make sure you are comparing like with like. The HFEA also gives the multiple birth rate, but a high rate doesn’t suggest a good clinic which has your best interests at heart. Naturally multiple births occur in 1 in 80 of all pregnancies, it’s around one in six after IVF. That may sound positive, but in fact multiple birth is the single biggest risk after fertility treatment. 1 in 12 multiple pregnancies ends in death or disability for one or more babies, and it is also more risky for mothers. Good clinics should not have very high twin rates. A really good clinic will have good success rates and low multiple rates.

When it comes to success rates, don’t get bogged down in fairly small percentage differences – in general they’re probably not that meaningful.

NHS Funding

You will also want to know if you qualify for NHS funding. The guideline from NICE recommends 3 full cycles (fresh and transfer of any frozen embryos) for women of 39 and under and one full cycle for women of 40-42 who have had no previous treatment, who have a good ovarian reserve and who have spent 2 years trying)

In England funding comes from your local CCG (Clinical Commissioning Group) not your clinic so you need to find out their rules – and unfortunately they all make their own up as the NICE guideline is only a guideline. You can find out what your CCG is offering by visiting the Fertility Fairness website. The CCG will also set eligibility criteria – and each will have their own

Location

Think about how close the clinic is to your home or workplace. Be realistic as a long journey is fine as a one-off, but think about doing it three or four times a week. Ask the clinic how often you will have to visit as some will want you in every day of the cycle, but others just a few times a week.

Think about how you will get there and how long the journey will take? Are you going to use public transport or drive? Will you be travelling in the rush hour? Can the clinic offer early morning appointments or will you need to take time off work? Will it fit around your job?

Cost

Fertility treatment prices are not regulated and can vary hugely. Clinics that charge more are not necessarily better so do look into prices. The headline figure on clinic websites is rarely the total cost of treatment – ask instead what the average person actually pays

The HFEA does require clinics to offer you a personalised costed treatment plan, but check what is included – drugs, counselling, scans and bloods, freezing and storing spare embryos, follow-up consultations etc.

Unproven treatments

Many clinics offer unproven additional treatments. Many are not scientifically proven. The HFEA has advice on some of these . Additional treatments can be very expensive, and you may risk paying a lot for something that may not make a difference – and may even bring additional risks.

Support

Will there be someone you can call with any problems/concerns? You should be given a contact to call if you are concerned about anything at any time. And is counselling included in the cost of treatment? You may think you don’t want or need it, you may may find it helpful once you have started treatment. So check if you are going to have to pay for counselling, and if it is included, ask how many sessions.

Is there a counsellor based at the clinic? Some counsellors also offer telephone counselling and you can find a list of fertility counsellors on the British Infertility Counselling Association website. Is there a patient support group?

Waiting

How soon could you get an appointment and when could you start treatment if it is recommended ? How long are waiting times for donor eggs or sperm? At some clinics,
there are still waiting lists for donor eggs and sperm but others have plenty of donors, so do check.k

Do you like the clinic?

I think this is far more important than you might initially think.

Talk to anyone else you know who has been there, look online for views – but remember that everyone is different. Go to any open days or meetings for prospective patients and think if the clinic feels right for you. It may sound ridiculous, but it matters.

Trust your instincts, and don’t hink they don’t matter. Make sure that you have chosen a clinic that you will be happy with.

Treatment isn’t always easy, but it is certainly much easier if you are being looked after by people you like and trust.

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Fertility Matters is written by Kate Brian who has been through fertility problems, tests and IVF treatment herself. The website gives reliable information, advice and support to anyone who is having difficulties getting pregnant. Read more